NCT03488550

Brief Summary

This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2018

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

March 28, 2018

Last Update Submit

August 19, 2020

Conditions

Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability as measured by the occurrence of adverse events

    Day 56

Secondary Outcomes (2)

  • Serum plasma concentration of ANX007 after a single IVT injection.

    Day 15

  • Immunogenicity of ANX007 after a single IVT injection.

    Day 56

Other Outcomes (1)

  • Effect of a single IVT injection of ANX007 on serum C1q

    Day 15

Study Arms (1)

ANX007-GLA-01

EXPERIMENTAL
Biological: ANX007

Interventions

ANX007BIOLOGICAL

Single ascending dose

ANX007-GLA-01

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female age 18 years and older
  • Diagnosis of primary open-angle glaucoma
  • Intraocular pressure \<21 mm Hg on a stable IOP treatment regimen
  • Reliable visual field testing

You may not qualify if:

  • BCVA worse than 20/80 in either eye
  • Extensive glaucomatous visual-field damage
  • History of intraocular inflammatory or infectious eye disease in study eye
  • Ocular trauma in study eye within the preceding 6 months
  • History of uncomplicated cataract surgery less than 6 mos prior
  • Any abnormality preventing reliable Tonopen tonometry in study eye
  • Active malignancy within past 5 yrs
  • Previous tx with another humanized monoclonal antibody
  • History of any autoimmune or neurologic disease
  • Concurrent use of glucocorticoid medications
  • Receiving monoamine oxidase inhibitor therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Related Links

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Eric Humphriss

    Annexon Vice President of Clinical Operations

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 5, 2018

Study Start

March 23, 2018

Primary Completion

August 3, 2018

Study Completion

August 3, 2018

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations

US(1)